CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
50,000 IU vitamin D3 +1 moredrug
Likely dose
50,000 IU vitamin D3from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02328404
NCT02328404Phase 3Completed
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The Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance Among Overweight Jordanian Women With Polycystic Ovary Syndrome in Irbid

Hayat Pharmaceutical Co. PLC·interventional·Posted Dec 31, 2014·Updated Aug 4, 2016

In Brief

A Phase 3 clinical trial evaluating 50,000 IU vitamin D3 and Placebo for Polycystic Ovary Syndrome and Hypovitaminosis D. Completed, enrolled 60 participants across 1 site.

Detailed Summary

This is a prospective double-blind, randomized, parallel-group, placebo-controlled trial designed to examine the effect of supplementation with 50,000 IU vitamin D3 for 3 months on Polycystic Ovary Syndrome (PCOS) prognosis, serum 25-Hydroxy Vitamin D (25(OH)D) level, serum chromium level, insulin resistance, and Body Mass Index (BMI), in 60 overweight Jordanian female patients diagnosed with PCOS and with hypovitaminosis D.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome, Hypovitaminosis D
CountriesJordan
CollaboratorsJordan University of Science and Technology

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 31, 2014
Enrollment StartFeb 1, 2014
Primary CompletionSep 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.5 years ago

Interventions

50,000 IU vitamin D3drug

Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU

Placebodrug

Placebo film-coated tablet of Biodal 50,000 IU